Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06884280

Comparing High and Low Dose Iron Treatments for People on Peritoneal Dialysis: The PALaDIN Study

Led by Hull University Teaching Hospitals NHS Trust · Updated on 2026-05-06

30

Participants Needed

1

Research Sites

98 weeks

Total Duration

On this page

Sponsors

H

Hull University Teaching Hospitals NHS Trust

Lead Sponsor

P

Pharmacosmos Therapeutics, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

Chronic kidney disease affects a significant portion of the UK population, with approximately 3.5 million adults diagnosed. At its most severe stage, end-stage kidney disease, individuals require frequent dialysis treatment. One form of dialysis, known as peritoneal dialysis, involves introducing and removing fluid from the abdominal cavity to help filter out toxins from the body. The kidneys are involved in various hormonal processes, including those responsible for producing red blood cells, making anaemia a common consequence of kidney failure. When designing a clinical trial to evaluate the effectiveness of any treatment, it is essential to determine the number of suitable and willing participants, as well as those who can complete all required tests and measurements. Identifying the most appropriate measurement to assess the impact of intravenous iron (iron injected directly into veins) is crucial to ensure that any observed changes are meaningful to people with CKD and their carers. To address these considerations, the investigators will conduct a pilot feasibility trial. In this trial, individuals with kidney disease undergoing peritoneal dialysis will be randomly assigned to receive either high-dose or low-dose intravenous iron, or oral iron therapy. Over twelve months, the investigators will monitor their anaemia response, symptoms of kidney disease, quality of life, physical performance (such as the ability to walk for six minutes), and cognitive function. Additionally, the investigators will assess the impact of each intervention on the frequency of blood transfusions, whether those on oral iron require intravenous iron, and any changes in the dosage of erythropoietin-stimulating agents (drugs that increase blood production).

CONDITIONS

Official Title

Comparing High and Low Dose Iron Treatments for People on Peritoneal Dialysis: The PALaDIN Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Males and females aged 6518 years
  • Able to give informed consent
  • Serum ferritin less than 700 ug/L
  • Transferrin saturation level less than 40%
  • No intravenous iron in the last 4 weeks before randomisation (patients may be included after a 4-week washout period)
  • On maintenance peritoneal dialysis therapy for at least 4 weeks
  • Expected to remain on peritoneal dialysis therapy for the duration of the study
Not Eligible

You will not qualify if you...

  • Inadequate dialysis as determined by the responsible clinician
  • Likely need for blood transfusion within 1 week of enrolment
  • Taking or received HIF-PHI in the past 4 weeks
  • Planned major surgery that may affect treatment response
  • Diagnosed with haemochromatosis or haemosiderosis or ALT more than 3 times normal
  • Considered suitable only for best-supportive or end-of-life care at screening
  • Women of childbearing potential not using effective contraception
  • Participated in another medicinal study (CTIMP) within past 4 weeks
  • Known allergy or adverse reaction to oral or intravenous iron
  • C-reactive protein over 50, transferrin saturation over 40%, or serum ferritin over 700 at recruitment
  • Active infection, HIV, or active Hepatitis B or C
  • Unable or unwilling to consent to or complete study procedures

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hull University Teaching Hospitals NHS Trust

Hull, East Riding Of Yorkshire, United Kingdom, HU3 2JZ

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Comparing High and Low Dose Iron Treatments for People on Peritoneal Dialysis: The PALaDIN Study | DecenTrialz